Mark Wilcox, professor of medical microbiology at the University of Leeds, said Seres Therapeutics Inc.’s top-line phase III data with oral microbiome therapeutic SER-109 against recurrent Clostridium difficile infection (CDI) are “about as good as it gets” in the tough-to-treat patient population. Read More
Shares of Omeros Corp. (NASDAQ:OMER) jumped 50.9% to $21.32 on Aug. 10 after it reported that six critically ill COVID-19 patients treated with its investigational lectin-pathway inhibitor, narsoplimab, recovered from the disease. The company said it will now seek government support to accelerate the drug’s large-scale manufacture. "We look forward to being able to make narsoplimab broadly available to hospitalized COVID-19 patients," said Omeros CEO Greg Demopulos. Read More
Astrazeneca plc has reached an agreement with Shenzhen-based Kangtai Biological Products Co. Ltd. to produce its COVID-19 vaccine AZD-1222 in China. The Chinese firm is required to produce at least 100 million doses by the end of the year, and at least 200 million doses by the end of 2021. Read More
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines. Read More
Knocked back by a complete response letter (CRL) in late 2018, Trevena Inc. dusted itself off, resubmitted its NDA for oliceridine and found satisfaction as the FDA has approved the opioid agonist. Read More
Investigators have developed a new approach to classifying neurodegenerative disorders that used the overall patterns of protein aggregation, rather than specific proteins, to define six clusters of patients that crossed traditional diagnostic categories. Read More
HONG KONG – Tel Aviv-based Teva Pharmaceutical Industries Ltd. has inked an exclusive strategic agreement with Reykjavik, Iceland-based Alvotech hf to commercialize five biosimilar product candidates in the U.S. Read More
Nearly three years after an FDA rejection of Eagle Pharmaceuticals Inc.'s initial effort to add exertional heat stroke (EHS) to the list of approved indications for Ryanodex (dantrolene sodium), its efforts have again been met with a complete response letter. The calcium channel modulator is already approved for the treatment of malignant hyperthermia (MH), but Eagle said it has decided to drop further pursuit of EHS. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boehringer Ingelheim, BMS, Dragonfly, Gigagen, Ibio, Isotherapeutics, Janssen, Lilly, Pieris, Monopar, Northstar, Novocellbio, Onko, Pharmamar, Secura, Verastem. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anaptysbio, Avadel, Axsome, BMS, Eli Lilly, Enlivex, Genentech, Humanigen, Innovent, Kamada, Krystal, Logicbio, Ovid, Pharming, Precigen, Rhovac, Seres. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Aquestive, Chi-Med, Diurnal, Gilead, Mallinckrodt, Ocugen, Pluristem, Reata, Seelos, Trevena, Vaxart. Read More
New hires and promotions in the biopharma industry, including: Atea, Eidos, Emerald, Mimedx, NBE, Nordic Nanovector, Oasmia, Spark, Terns, Topalliance. Read More
